Greg Hookings

Greg Hookings, director of Digital Industries, Stratus Technologies.

It’s no secret that staying competitive requires businesses, regardless of industry, to evolve, grow, and innovate. It’s a fact that the global pharmaceutical industry is not immune to.

 shows that 26 of the 30 largest global pharmaceutical companies have announced major transformations. So, the need is clear and many businesses in the space have taken action, but the results have left something to be desired. The report goes on to explain that less than one-third of surveyed respondents, all of whom had been part of a transformation effort, said their companies’ transformations had achieved a sustained performance improvement.

Digital transformation has become essential for pharmaceutical manufacturing companies. The leaders and executives of these businesses face increasing pressure to follow complex regulation frameworks, decrease costs, manage supply chains, and ensure quality for every single product. All of that is coupled with the goal of achieving Pharma 4.0—in which these companies adapt digital strategies to the unique, complex world of pharmaceutical manufacturing.

But reaching the point of Pharma 4.0 is not a straightforward path. Creating a meaningful digital transformation requires pharmaceutical manufacturing companies to incorporate the right technologies, processes, and systems to reach their fullest potential. So, what tools should these companies start with? One of the most important places to start is with edge computing.

As it stands, a major priority in the pharmaceutical manufacturing industry centers around the need for more operational efficiency. And according to the 

, more companies are opting for a new approach with data-driven manufacturing models.

With more traditional pharmaceutical manufacturing models, there are often several inefficiencies that cause serious disruption—siloed processes, rigid production environments, and a lack of interoperability. These factors bring a negative impact for pharmaceutical manufacturers, providing them with poor visibility into both operations and assets that are directly linked to quality and productivity. When visibility suffers, maintaining compliance becomes increasingly difficult and complex, hampering a company’s reputation, and opening it up to increased risk.

However, the pharmaceutical manufacturing industry’s conservative nature makes it difficult to quickly adopt and implement new technologies. Even still, another report from the 

 has found that improving operational efficiency is actually the top business priority for pharmaceutical organizations globally. 

And 35% of pharmaceutical and life sciences organizations worldwide say innovation is instrumental to reaching this goal. As pharmaceutical manufacturers attempt to tap into Pharma 4.0 and maintain a competitive advantage, they are increasingly relying on edge computing to transform operations, expand production, and deliver more end-to-end drug development and manufacturing services.

Edge Computing’s Impact on Pharmaceutical Manufacturing Production

Edge computing platforms enable continuous improvement in operational performance, thanks to its reliable data integrity, predictive health capabilities, and integration of operational systems with enterprise applications. Pharmaceutical companies have highly stringent regulatory requirements to follow and any system failures could prove damaging and highly disruptive to every part of operations, not to mention reputation.

With Edge computing, manufacturers can continuously monitor system health, diagnose issues, and perform self-healing actions to ensure system availability at all times. And because edge computing provides enhanced data security and real-time monitoring, pharmaceutical manufacturers can ensure that their data remain secure while guaranteeing that batch productions are at the highest quality.

Because data in an edge computing environment are continuously available, pharmaceutical manufacturing executives are able to validate operating technologies and processes or document adherence to good manufacturing practice (GMP) regulations, which on its own is a highly time-consuming process. With the right edge platform, companies can automate the collection, analysis, and reporting of critical production data while remaining confident that data and mission-critical applications are continuously available.

Utilizing edge computing also offers manufacturers an option without unplanned downtime, enabling companies to comply with even the strictest regulations. Edge computing solutions also support process analytical technology (PAT) and QbD processes with continuous availability.

As the importance of edge computing for operations continues to crystalize in the pharmaceutical manufacturing industry, it’s also become critical that these companies understand how to balance both information technology (IT) and operational technology (OT), ensuring both sets of teams are working together. For OT teams, that means ensuring they have the tools to tap into new automation programs and maintain continuous availability for critical applications. And on the IT side, manufacturers need to make sure they are providing a solution that adds interoperability, easy manageability, cost efficiency, and support to meet cybersecurity requirements.

By bringing together automation systems that control the full range of both physical processes and digital systems dedicated to information processing and overcoming data fragmentation to create enterprise-wide data governance, companies can create a 360-degree view of assets, workforces, and processes and how they all intertwine with operations, IT, and business units.Edge computing helps meet the needs of both IT and OT teams enabling by:

Appropriately informing, automating, and augmenting use cases for both IT and OT teams.

Monitoring and addressing data accessibility and availability in the production environment.

Offering a platform for intelligent process modeling, allowing IT and OT teams to extract value from real-time data efficiently.

Edge computing helps to bridge the gap, empowering each group to work more efficiently and in harmony with one another. With edge platforms, manufacturers can bring applications into the production environment, ensuring continuous data availability. That allows OT teams to run operations, while minimizing the risk of human error and mistakes in the process. And that level of accuracy in turn helps keep data management in line with IT standards, reducing cybersecurity risks—a win-win for everyone involved.

In one way or another, Pharma 4.0 is the end-goal for every pharmaceutical manufacturer. But the road that leads toward achieving that goal requires the right tools to move forward and transform effectively.

A successful transformation project will allow for greater speed in both production and decision-making, resulting in lower operating costs and total cost of ownership, while delivering quality by design.

And the key to that success lies at the edge. With edge computing platforms, pharmaceutical manufacturers, IT, and OT teams gain the tools they need to quickly gather insights and make more impactful decisions that drive productivity while keeping businesses compliant. Ultimately, Pharma 4.0 is something that is far more reachable than pharmaceutical manufacturers might think. Edge computing can help them get there.

Articles

Creating a meaningful digital transformation requires pharmaceutical manufacturing companies to incorporate the right technologies, processes, and systems to reach their fullest potential. 